Trial Outcomes & Findings for Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients (NCT NCT02926573)

NCT ID: NCT02926573

Last Updated: 2018-08-08

Results Overview

Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 123 participants
• Primary outcome timeframe: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.
• Results posted on: 2018-08-08

Participant Flow

The study opened to participant enrollment on 06/24/2016 and closed to participant enrollment on 06/30/2017.

13 participants were enrolled but withdrew prior to study participation with no medication given. 8 participants withdrew due to patient preference and 5 withdrew due to cancellation of surgery.

Participant milestones

Measure	Gabapentin Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo Placebo liquid by mouth or Per Tube twice a day
Overall Study STARTED	55	55
Overall Study COMPLETED	44	46
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Measure	Gabapentin Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo Placebo liquid by mouth or Per Tube twice a day
Overall Study Nausea	1	0
Overall Study Remain intubated	2	2
Overall Study Change in surgery plan	3	1
Overall Study Change to outpatient status	5	1
Overall Study Withdrawal by Subject	0	2
Overall Study Return to operating room	0	2
Overall Study Delirium	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Gabapentin n=44 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=46 Participants Placebo liquid by mouth or Per Tube twice a day	Total n=90 Participants Total of all reporting groups
Age, Continuous	61.1 years STANDARD_DEVIATION 11.3 • n=44 Participants	60.9 years STANDARD_DEVIATION 10.0 • n=46 Participants	61.0 years STANDARD_DEVIATION 10.6 • n=90 Participants
Sex: Female, Male Female	11 Participants n=44 Participants	10 Participants n=46 Participants	21 Participants n=90 Participants
Sex: Female, Male Male	33 Participants n=44 Participants	36 Participants n=46 Participants	69 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	44 participants n=44 Participants	46 participants n=46 Participants	90 participants n=90 Participants
Participant's opinion on effectiveness of narcotic pain medication Low effectiveness	8 Participants n=37 Participants • Some participants were not included as they had never had narcotic pain medication prior to surgery.	10 Participants n=42 Participants • Some participants were not included as they had never had narcotic pain medication prior to surgery.	18 Participants n=79 Participants • Some participants were not included as they had never had narcotic pain medication prior to surgery.
Participant's opinion on effectiveness of narcotic pain medication High effectiveness	29 Participants n=37 Participants • Some participants were not included as they had never had narcotic pain medication prior to surgery.	32 Participants n=42 Participants • Some participants were not included as they had never had narcotic pain medication prior to surgery.	61 Participants n=79 Participants • Some participants were not included as they had never had narcotic pain medication prior to surgery.
Participant's experience with significant amount of daily pain No daily pain	40 Participants n=43 Participants • 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm)	36 Participants n=44 Participants • 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm)	76 Participants n=87 Participants • 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm)
Participant's experience with significant amount of daily pain Daily pain	3 Participants n=43 Participants • 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm)	8 Participants n=44 Participants • 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm)	11 Participants n=87 Participants • 3 responses are missing because surveys were not given (1 in the gabapentin arm and 2 in the placebo arm)

PRIMARY outcome

Timeframe: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.

Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.

Outcome measures

Measure	Gabapentin n=44 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=46 Participants Placebo liquid by mouth or Per Tube twice a day
Change in Daily Narcotic Consumption	1.60 mg/hour Interval 0.0 to 6.11	1.59 mg/hour Interval 0.0 to 5.84

SECONDARY outcome

Timeframe: Once on post-op day 2 or day of discharge, whichever comes first

Population: The participants who did not answer this question on the survey were not evaluable for this outcome measure.

-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.

Outcome measures

Measure	Gabapentin n=42 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=43 Participants Placebo liquid by mouth or Per Tube twice a day
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled Never	1 Participants	0 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled Sometimes	1 Participants	6 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled Usually/Always	40 Participants	37 Participants

SECONDARY outcome

Timeframe: Once on post-op day 2 or day of discharge, whichever comes first

-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.

Outcome measures

Measure	Gabapentin n=42 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=43 Participants Placebo liquid by mouth or Per Tube twice a day
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain Never	0 Participants	0 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain Sometimes	0 Participants	2 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain Usually	5 Participants	5 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain Always	37 Participants	36 Participants

SECONDARY outcome

Timeframe: Once on post-op day 2 or day of discharge, whichever comes first

-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.

Outcome measures

Measure	Gabapentin n=42 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=43 Participants Placebo liquid by mouth or Per Tube twice a day
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control Neutral	2 Participants	0 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control Somewhat dissatisfied	0 Participants	2 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control Very satisfied	30 Participants	34 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control Somewhat satisfied	7 Participants	5 Participants
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control Dissatisfied	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline through post operative day 3

• Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.
• Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain

Outcome measures

Measure	Gabapentin n=42 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=43 Participants Placebo liquid by mouth or Per Tube twice a day
Mean Pain With Resting Score as Measured by VAS Post-operative Day 1 7AM	44 mm Standard Deviation 26.9	46 mm Standard Deviation 24.9
Mean Pain With Resting Score as Measured by VAS Post-operative Day 1 10AM	29 mm Standard Deviation 26.5	37 mm Standard Deviation 28.2
Mean Pain With Resting Score as Measured by VAS Post-operative Day 1 7PM	25 mm Standard Deviation 25.3	32 mm Standard Deviation 25.9
Mean Pain With Resting Score as Measured by VAS Post-operative Day 2 7AM	27 mm Standard Deviation 26.2	32 mm Standard Deviation 24.5
Mean Pain With Resting Score as Measured by VAS Post-operative Day 2 10AM	23 mm Standard Deviation 23.3	30 mm Standard Deviation 22.4
Mean Pain With Resting Score as Measured by VAS Post-operative Day 2 7PM	25 mm Standard Deviation 24.3	33 mm Standard Deviation 25.7
Mean Pain With Resting Score as Measured by VAS Post-operative Day 3 7AM	22 mm Standard Deviation 22.4	32 mm Standard Deviation 26.1

SECONDARY outcome

Timeframe: Baseline through post operative day 3

• Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.
• Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain

Outcome measures

Measure	Gabapentin n=42 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=43 Participants Placebo liquid by mouth or Per Tube twice a day
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 1 7AM	36 mm Standard Deviation 27.9	46 mm Standard Deviation 26.7
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 1 10AM	36 mm Standard Deviation 30.0	45 mm Standard Deviation 28.2
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 1 7PM	34 mm Standard Deviation 26.5	41 mm Standard Deviation 27.4
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 2 7AM	34 mm Standard Deviation 27.0	39 mm Standard Deviation 27.6
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 2 10AM	28 mm Standard Deviation 23.3	39 mm Standard Deviation 28.5
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 2 7PM	30 mm Standard Deviation 25.1	45 mm Standard Deviation 29.7
Mean Pain With Coughing Score as Measured by VAS Post-operative Day 3 7AM	27 mm Standard Deviation 24.1	39 mm Standard Deviation 27.1

SECONDARY outcome

Timeframe: Baseline through post operative day 3

• Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to "Please rate your current pain level with no movement (rest), with a cough, and with a swallow". Subjects marked a point on a 100-mm line anchored "no pain" on the left end and "worst possible pain" on the right end.
• Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain

Outcome measures

Measure	Gabapentin n=42 Participants Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=43 Participants Placebo liquid by mouth or Per Tube twice a day
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 1 7AM	49 mm Standard Deviation 32.3	48 mm Standard Deviation 30.7
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 1 10AM	46 mm Standard Deviation 33.8	51 mm Standard Deviation 31.3
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 1 7PM	41 mm Standard Deviation 29.2	52 mm Standard Deviation 28.5
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 2 7AM	41 mm Standard Deviation 30.1	48 mm Standard Deviation 28.9
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 2 10AM	37 mm Standard Deviation 29.5	45 mm Standard Deviation 29.8
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 2 7PM	40 mm Standard Deviation 29.3	56 mm Standard Deviation 29.3
Mean Pain With Swallowing Score as Measured by VAS Post-operative Day 3 7AM	35 mm Standard Deviation 28.0	52 mm Standard Deviation 30.5

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 50 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gabapentin n=55 participants at risk Gabapentin liquid by mouth or per Tube 300mg twice a day	Placebo n=55 participants at risk Placebo liquid by mouth or Per Tube twice a day
Metabolism and nutrition disorders Acidosis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Renal and urinary disorders Acute kidney injury	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Renal and urinary disorders Acute renal failure	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Psychiatric disorders Agitation	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Airway bleed	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Airway edema	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Alkalosis	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Immune system disorders Allergic contact dermatitis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Blood and lymphatic system disorders Anemia	58.2% 32/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	63.6% 35/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Psychiatric disorders Anxiety	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Aspiration	7.3% 4/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Atrial fibrillation	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Atrioventricular block	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Bleeding at wound site	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Bloody sputum	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Eye disorders Blurry vision	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Bradycardia	10.9% 6/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	12.7% 7/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Chest pain	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
General disorders Chills	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Renal and urinary disorders Chronic kidney disease	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Congestive heart failure exacerbation	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Constipation	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Psychiatric disorders Delerium	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Psychiatric disorders Delirium/alcohol withdrawal	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Psychiatric disorders Depression	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Diarrhea	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Eye disorders Diplopia	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Dysphagia	10.9% 6/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Investigations Elevated alkaline phosphatase	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Investigations Elevated liver enzymes	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Blood and lymphatic system disorders Elevated white blood cells	52.7% 29/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	65.5% 36/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Eye disorders Eye pain	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Eye disorders Eye tingling	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Fall	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
General disorders Fever	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Flap necrosis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Hematochezia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Vascular disorders Hematoma	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Hematoma at flap site	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Renal and urinary disorders Hematuria	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Hemorrhage at resection site	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hyperglycemia	20.0% 11/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	9.1% 5/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hyperkalemia	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypernatremia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Vascular disorders Hypertension	67.3% 37/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	72.7% 40/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypoalbuminemia	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypocalcemia	25.5% 14/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	12.7% 7/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypoglycemia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypokalemia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypomagnesemia	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hyponatremia	16.4% 9/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	16.4% 9/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Endocrine disorders Hypoparathyroidism	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypophosphatemia	25.5% 14/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	10.9% 6/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Vascular disorders Hypotension	12.7% 7/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Iatrogenic bradycardia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Ileus	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Infection	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Lactic acidosis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Laryngeal hemorrhage	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Left arm surgical site cellulitis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Nervous system disorders Left neck numbness	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Musculoskeletal and connective tissue disorders Left shoulder weakness	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
General disorders Left upper extremity swelling	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Blood and lymphatic system disorders Microcytic anemia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Nervous system disorders Myasthenia gravis exacerbation	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Nausea	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
General disorders Neck fistula	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Vascular disorders Neck hematoma	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Neck infection	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Nonsustained ventricular tachycardia	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Oral wound dehiscence	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Oropharyngeal bleeding	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Vascular disorders Orthostasis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Oxygen desaturation	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Nervous system disorders Parasthesia (right foot)	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Pharyngeal leak	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Skin and subcutaneous tissue disorders Pressure ulcer - coccyx	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Pulmonary effusion	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Rectal bleeding	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Reflux	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Renal and urinary disorders Renal failure	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Nervous system disorders Right upper extremity tingling	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Sensation of reflux/burning with tube feeds	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Sepsis	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Sinus tachycardia	25.5% 14/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	21.8% 12/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
General disorders Stoma bleeding	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Stoma dehiscence	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Superficial dehiscence	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Superior thryroid artery bleed hematemesis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Supraventricular tachycardia	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Surgical site infection (MRSA)	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Blood and lymphatic system disorders Thrombocytopenia	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Blood and lymphatic system disorders Thrombocytosis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Vascular disorders Thrombosis	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Tongue edema	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Tracheitis	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Tracheostomy site bleeding	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Cardiac disorders Ventricular tachycardia	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Gastrointestinal disorders Vomiting	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	5.5% 3/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Investigations Weight loss	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Wound breakdown	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Infections and infestations Wound infection	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	3.6% 2/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Metabolism and nutrition disorders Hypochloremia	0.00% 0/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.	1.8% 1/55 • Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.

Additional Information

Melanie Townsend, M.D.

Washington University School of Medicine

Phone: 314-362-4470

Email: townsendm@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place